FDA 510(k)

Forwarts

Número K: K201366 · 2021-01-21

Data da decisão2021-01-21

Código do produtoGEH

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Forwarts is the device name listed in this FDA 510(k) record. The listed applicant is Pronova Laboratories BV. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K201366. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Forwarts?

Forwarts is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Pronova Laboratories BV. The 510(k) number is K201366.

When did Forwarts receive FDA 510(k) clearance?

Forwarts received FDA 510(k) clearance on 2021-01-21, under 510(k) number K201366.

Who is the listed applicant for Forwarts?

The FDA 510(k) record lists Pronova Laboratories BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Forwarts?

The FDA product code for Forwarts is GEH.

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